National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK)
National Heart, Lung, and Blood Institute (NHLBI)Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
National Institute of Neurological Disorders and Stroke (NINDS))

This FOA will utilize the NIH Clinical Trial Planning Grant
(R34) to support the development of clinical trials in individuals with type 1
diabetes. Contingent on the merit of the proposed trials and the availability
of funds, NIH anticipates funding of up to three full scale trials from the
funded R34 planning grants. During the early funding period of the R34
grant, the investigators will have the opportunity to revise the protocol based
on considerations raised in peer review. NIH will then seek external
input that will guide priorities for the support of a limited number of full
clinical trials selected from the funded R34 protocols. Those clinical
trials will be conducted in collaboration with a single data coordinating
center that will be awarded through a future FOA. The data coordinating center
will work with R34 awardees to finalize the protocol and budget, complete
administrative tasks and recruit clinical sites. The data coordinating
center award will provide support for the conduct of the selected trials.
Clinical trials developed under R34 grants that are not prioritized for
implementation through this data coordinating center may be appropriate for
support through other funding sources or mechanisms.

NIDDK
is amending Section I, paragraph four to add the following: Depending on the merit and cost of
the clinical trials proposed in the applications, only a single award may be
made, should the most meritorious application for a clinical trial utilize all
available funds.

NIDDK
is also deleting the following sentences: Those clinical trials will be conducted
in collaboration with a single data coordinating center that will be awarded
through a future FOA. The data coordinating center will work
with R34 awardees to finalize the protocol and budget, complete administrative
tasks and recruit clinical sites. The data coordinating center award will
provide support for the conduct of the selected trials.

NIDDK is adding this sentence: These trials will
be funded through a future FOA.

NEW
LANGUAGE

Section
I. Funding Opportunity Description, paragraph four

This FOA will utilize the NIH Clinical Trial Planning Grant
(R34) to support the development of clinical trials in individuals with type 1
diabetes. Contingent on the merit of the proposed trials and the availability
of funds, NIH anticipates funding of up to three full scale trials from the
funded R34 planning grants. Depending
on the merit and cost of the clinical trials proposed in the applications, only
a single award may be made, should the most meritorious application for a
clinical trial utilize all available funds. During the early
funding period of the R34 grant, the investigators will have the opportunity to
revise the protocol based on considerations raised in peer review. NIH
will then seek external input that will guide priorities for the support of a
limited number of full clinical trials selected from the funded R34
protocols. These trials will be funded through a future FOA. Clinical
trials developed under R34 grants that are not prioritized for implementation
may be appropriate for support through other funding sources or mechanisms.